Multiresistant intestinal bacteria in patients with kidney and liver transplantation: multicenter study and clinical trial.

• Conditions: Colonization by multiresistant enterobacteria in patients who underwent liver and renal transplants; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-004838-15-ES
• Lead Sponsor: Mª Carmen Fariñas Álvarez. Hospital Universitario Marques de Valdecilla

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-04
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All patients undergoing a liver or kidney transplants in the participating hospitals with a multiresistant enterobacteria positive rectal swab previous to transplant, during the study period, and sign the informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 158
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

Patients aged < 18 years, hospitalized patients over 48 hours before transplantation, treated (previous week) or who are being treated with antibiotics active against multiresistant enterobacteria, presence of contraindications to the drugs used in the study, resistance of the colonizing enterobacteria strain isolated in rectal swabs to colistin (defined as MIC > 2mg/L).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified